Job Type
Full-time
Description
JOB SUMMARY: The Director, Global Regulatory Affairs plays a critical leadership role in guiding the regulatory team in navigating complex regulatory landscapes and ensuring compliance with all applicable regulations of ophthalmic implantable medical devices. Expertise contributes to creating and executing successful strategies for regulatory submissions, ensuring on time product approvals.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES: - Regulatory Strategy: Develop and implement comprehensive regulatory strategies to support the development, approval, and marketing of US Class II and III medical devices primarily in the US and Globally as needed.
- Compliance Oversight: Ensure that the company's products comply with regulatory standards (US FDA, EU MDR, UK, Canada, APAC, and other international regulations) throughout the product lifecycle.
- Submissions and Approvals: Lead the preparation, submission, and maintenance of regulatory filings for the US and other regions where the products are needed. In conjunction with Clinical Research, prepare or direct regulatory affairs staff in the generation of applications (i.e., IDE) for conducting clinical investigations. Generate/Oversee required submissions (progress reports, etc.) to support the continuation of clinical studies.
- Team Leadership: Manage and mentor a team of regulatory professionals, fostering professional growth and promoting a high-performance culture. Includes providing strategic leadership and guidance to RA team members embedded in project core teams, ensuring they effectively represent global regulatory requirements, manage timelines for submissions and approvals, and collaborate cross-functionally to support product development any necessary post-approval design changes. In addition is responsible for ensuring compliance with all employment regulations, requirements and performance expectations. This includes the development of direct reports and team members using Performance Objectives, training and development plans, Performance Appraisals, merit processes and Performance Management Plans to ensure success of the team.
- Cross-Functional Collaboration: Work closely with R&D, Quality Assurance, Marketing, and Manufacturing teams to align regulatory strategies with business objectives.
- Risk Management: Develop risk mitigation strategies related to regulatory compliance, audits, and product approvals. Lead responses to regulatory inquiries and inspection readiness activities.
- Product Labeling: Collaborate cross functionally to ensure compliance with global medical device labeling regulations by overseeing the creation and maintenance of all product labeling according to relevant standards and country specific requirements.
- Regulation and Standards Compliance: Leads the process for ensuring comprehensive compliance framework for assessing and integrating external standards and regulatory changes, ensuring alignment across cross-functional teams and driving proactive procedural updates.
- Stakeholder Management: Act as the primary liaison with regulatory authorities, managing relationships and communications with agencies such as the FDA, Notified Bodies, and Health Canada.
- Change Management: Stay abreast of evolving global regulatory requirements and implement changes within the organization as needed, ensuring continuous compliance.
- Oversee any field corrective actions.
- Supports management with the implementation of departmental strategies and company policies.
- Collaborate with cross functional teams to resolve complex project issues.
- Effectively plans and organizes team's work to ensure company objectives are met.
- Creates relationships with cross functional teams to ensure regulatory operational activities are in line with global business priorities
- Supports regulatory agency audits, as required.
- Contributes to the development of the RA budget by forecasting resource needs, estimating costs for submissions, recertifications and compliance activities and aligning financial planning the strategic regulatory objectives. Once budget is set, manages within plan and escalates if/when issues arise.
- Other duties as assigned.
Requirements
KNOWLEDGE, SKILLS AND ABILITIES:- Excellent interpersonal communication (oral and written), teamwork, leadership, organizational and negotiating skills
- Writes in a clear, concise, organized and convincing manner for the intended audience
- Solid critical analytical and problem-solving skills, including consistent and effective problem solving
- Strategic Thinking: Capability to develop and implement regulatory strategies that align with organizational goals.
- Builds and maintains constructive working relationships characterized by high level of acceptance, confidence, cooperation and mutual respect
- Promotes cooperation within and outside of the team to achieve goals and deliverables
- Ability to work under pressure and meet project timelines across departments
- Effective Communication: Ability to clearly and concisely convey information to diverse audiences, including regulatory bodies, internal and external stakeholders
- Strong leadership, diplomatic and motivational skills including the ability to lead up, across and down the business
- Proven ability to demonstrate drive for results and accountability of business needs
- Strong mentorship skills
- Flexible with proven ability to adjust to and lead a team through shifting priorities, demands and timelines
EDUCATION AND EXPERIENCE:- Bachelor's Degree in Regulatory Affairs or scientific discipline
- Advanced Degree in Regulatory Affairs, preferred
- RA certification (by Regulatory Affairs Professional Society), preferred
- Minimum of 12 years of experience in the area of international regulatory affairs (both submissions and compliance)
- 8+ years of progressive management experience
- 5+ years of experience working with business stakeholders within a cross-functional matrix environment
- 5+ years Class II and III Medical Device Company in Regulatory Affairs
- Experience managing a globally diverse, remote team
PHYSICAL REQUIREMENTS:- Must be able to remain in a stationary position at least 50% of the time.
- Occasionally move about inside the office and travel to and from office buildings to access file cabinets, employee offices, office machinery, etc. This may include, but is not limited to, bending and walking.
- Must be able to operate a computer and other office productivity machinery, such as a computer printer, computer keyboard, calculator, etc.
- Ability to listen and speak with employees and vendors. Must be able to exchange accurate information in these situations.
- View and type on computer screens for long periods of time.
- Ability to travel up to 10% of the time, as needed.
This description reflects management's assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.
Salary Description
$190,000-$226,000/year
